(155 days)
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia.
The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors. 2. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.
Let's break down the acceptance criteria and the supporting study for the QiF Blood and Fluid Warmer based on the provided 510(k) summary.
Key takeaway: This 510(k) submission is primarily focused on changing a contraindication to a precaution statement regarding plasma warming. The performance study is to demonstrate that the device still warms plasma to the specified temperature, thus maintaining equivalent performance to the predicate device. It is not a complex AI/imaging system.
Here's the information extracted and organized:
Acceptance Criteria and Reported Device Performance
Given that this is a medical device for warming fluids, the primary performance criterion is the ability to warm the fluid to a specified temperature.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device set point temperature | Plasma warmed to 38 ± 2 °C (98.6 ± 3.6 °F) |
| Device function as intended | Device functioned as intended in all instances |
| Equivalent performance to predicate | Demonstrated equivalent performance to its predicate device |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the performance tests. It broadly states that "Performance tests were performed."
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies an experimental setup to test fluid warming.
3. Number of Experts and Qualifications for Ground Truth:
- Not Applicable: This is a physical device warming a fluid to a specific temperature. The "ground truth" is established by direct temperature measurement using calibrated equipment, not by expert interpretation. There are no human experts involved in establishing this "ground truth."
4. Adjudication Method for the Test Set:
- Not Applicable: As there are no expert interpretations or subjective assessments involved, no adjudication method is necessary. The performance is measured objectively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No: This is not an imaging device or an AI assistant for human readers. Therefore, an MRMC study is not relevant or performed.
6. Standalone Performance (Algorithm Only):
- Yes (in concept, but not an "algorithm" as typically defined for AI): The device's primary function is to warm fluid to a set temperature. The performance study measures the device's ability to achieve this independent of human interaction (beyond initial setup and monitoring). The "algorithm" here would be the internal control system ensuring the desired temperature. The study directly assesses the device's own output temperature against the set point.
7. Type of Ground Truth Used:
- Objective Measurement/Physical Standard: The ground truth is the precise measurement of the warmed plasma's temperature, verified against the engineering specification of 38 ± 2 °C. This is a direct physical measurement.
8. Sample Size for the Training Set:
- Not Applicable: This is a hardware device with firmware, not a machine learning model that requires a "training set" in the common sense of data for a learning algorithm. The device's internal control system would have been developed through engineering design, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no "training set" in the machine learning context, this question is not relevant. The device's operational parameters (like the target temperature and its tolerance) are engineering specifications.
Summary of the study: The study performed was a verification test to ensure that the QiF Blood and Fluid Warmer consistently warms plasma to the specified temperature range (38 ± 2 °C). This was critical because the purpose of the 510(k) was to change a contraindication against plasma warming to a precaution, requiring proof that the warming function itself was adequate for plasma. The document explicitly states: "In all instances, the device functioned as intended and demonstrated equivalent performance."
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).